EBV InfectionPhase 3NCT04084626
PD1 Antibody and Lenalidomide as a Treatment for EBV-HLH or CAEBV
A Phase 3 study testing PD1 antibody and lenalidomide in people with EBV Infection, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
The present study was a prospective one-arm clinical study, in which EBV-HLH/chronic active EBV infection patients were selected as the main subjects to evaluate the effect of PD-1 antibody and lenalidomide regimens on ebv-dna and safety. Read more about this study
- Who is it for?
- Ages 1 year to 65 years
- Conditions the study is for
- EBV Infection
- What is being tested?
- PD1 antibody and lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2019to 1 Jul 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with CAEBV confirmed by 2016 Revised World Health Organization classification.
- If the patient has previously suffered CAEBV-HLH, the HLH should be in remission.
- A woman of childbearing age must be determined not to be pregnant by a pregnancy test and is willing to take effective measures to prevent pregnancy during the trial period and ≥12 months after the last administration of the drug; All male subjects used contraceptive methods during the study period and ≥6 months after the last administration;
- Ages Eligible for Study: 1 Year to 65 Years.
- Sign the informed consent.
Who cannot join
- Heart function above grade II (NYHA).
- Pregnancy or lactating Women.
- Allergic to PD-1 antibody or lenalidomide.
- Active bleeding of the internal organs.
- uncontrollable infection.
- Participate in other clinical research at the same time.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
jingshi wang
About this study
Official title: A Clinical Trial of Programmed Cell Death Protein 1(PD1) Antibody and Lenalidomide as a Treatment for Epstein-Barr Virus-associated Hemophagocytic Lymphohistiocytosis or Chronic Active EBV Infection(CAEBV)
The present study was a prospective one-arm clinical study, in which EBV-HLH/chronic active EBV infection patients were selected as the main subjects to evaluate the effect of PD-1 antibody and lenalidomide regimens on ebv-dna and safety.
- Conditions
- EBV Infection
- Being tested
- PD1 antibody, lenalidomide
- Medical subject headings
- Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD1 antibodyDrug
2mg/kg ivgtt on day 1(age<18 years); 200mg ivgtt on day 1(age >=18 years).
lenalidomideDrug
5mg orally once a day（age<18years) ,day 1-14; 10mg orally once a day(age>=18years), day 1-14.
| Study group | Role | What they receive |
|---|---|---|
| PD-1 antibody | Experimental | PD-1 antibody and lenalidomide administered in 2 week cycles for 6 cycles. Receives: Drug: PD1 antibody; Drug: lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
The rate of decline in EBV-DNA copy (defined as a 2log decrease in EBV-DNA copy) or negative rate in peripheral blood mononuclear cells and plasma
Measured: 6 months
Secondary outcomes (3)
Spleen size
ultrasonic spleen size
Measured: 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Adverse events including thyroid function， liver function damage, myelosuppression, infection, bleeding and so on.
Measured: through study completion, an average of 1 years
survival
from the date of inclusion to date of death, irrespective of cause Adverse Events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start15 Sep 2019
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EBV InfectionStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Wang, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084626
- Sponsor's protocol ID
- PD-1 antibody-EBV
- Status last verified
- Jan 2022
- First submitted
- 8 Sep 2019
- Last updated
- 5 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Programmed Cell Death Protein 1(PD1) Antibody and Lenalidomide as a Treatment for Epstein-Barr Virus-associated Hemophagocytic Lymphohistiocytosis or Chronic Active EBV Infection(CAEBV)
- ClinicalTrials.gov ID
- NCT04084626
- Acronym / sponsor ID
- PD-1 antibody-EBV
- Conditions
- EBV Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study was a prospective one-arm clinical study, in which EBV-HLH/chronic active EBV infection patients were selected as the main subjects to evaluate the effect of PD-1 antibody and lenalidomide regimens on ebv-dna and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-1 antibody | Experimental | Drug: PD1 antibody, Drug: lenalidomidePD-1 antibody and lenalidomide administered in 2 week cycles for 6 cycles. |
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with CAEBV confirmed by 2016 Revised World Health Organization classification.
- If the patient has previously suffered CAEBV-HLH, the HLH should be in remission.
- A woman of childbearing age must be determined not to be pregnant by a pregnancy test and is willing to take effective measures to prevent pregnancy during the trial period and ≥12 months after the last administration of the drug; All male subjects used contraceptive methods during the study period and ≥6 months after the last administration;
- Ages Eligible for Study: 1 Year to 65 Years.
- Sign the informed consent.
Key exclusion criteria (6 listed)
- Heart function above grade II (NYHA).
- Pregnancy or lactating Women.
- Allergic to PD-1 antibody or lenalidomide.
- Active bleeding of the internal organs.
- uncontrollable infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD1 antibody2mg/kg ivgtt on day 1(age<18 years); 200mg ivgtt on day 1(age >=18 years). | Drug | PD-1 antibody |
| lenalidomide5mg orally once a day（age<18years) ,day 1-14; 10mg orally once a day(age>=18years), day 1-14. | Drug | PD-1 antibody |
Primary outcome
Response rate
Time frame: 6 months
The rate of decline in EBV-DNA copy (defined as a 2log decrease in EBV-DNA copy) or negative rate in peripheral blood mononuclear cells and plasma
3 secondary outcomes
Spleen size
Time frame: 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: through study completion, an average of 1 years
survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PD1 antibody and lenalidomide in people with EBV Infection, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jingshi wang (86-010-63139862, wangjingshi987@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.